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Partner, Washington, D.C.

Elizabeth Fawell navigates the detailed, and often complex, regulatory issues confronting food companies and helps them understand both the rules and various risks involved so that they can make informed business decisions. Elizabeth works with every segment of the food industry, including manufacturers, distributors, retailers, restaurants, and food service operators; and their trade associations.  Elizabeth's work on behalf of food industry clients with the Food Safety Modernization Act (FSMA) since its inception and her understanding of Hazard Analysis Critical Control Point (HACCP) systems provides her with the experience and perspective needed as she counsels clients on how to comply with new requirements under the law. Elizabeth is a Preventive Controls Qualified Individual (PCQI) and has completed the FSPCA PCQI training.

Elizabeth knows how laws, regulations, and guidance documents are developed, interpreted, and enforced. Her extensive knowledge enables clients to prevent and respond to enforcement actions such as Warning Letters, Import Alerts, and agency investigations. She helps clients in determining whether an RFR is necessary and whether a recall is warranted. If so, she helps manage the recall to minimize business impacts. Elizabeth provides real-time advice during factory inspections, helps clients prepare 483 responses, and drafts inspection manuals. She also assists clients in lawfully and creatively promoting their products; such as the development of labels, claims, and website and promotional campaigns. Elizabeth also supports clients in advertising disputes and with responses to FTC and Attorney General investigations.

Elizabeth helps clients stay informed of and ahead of public policy issues and develops strategies for effective advocacy before regulators. She also counsels clients on compliance with Consumer Product Safety Commission (CPSC) safety standards, testing and certification requirements, and reporting obligations.

Elizabeth is a member of the Food and Dietary Supplements Committee of the Food and Drug Law Institute.

The CDC recently released updated its guidance on the criteria for determining when a worker diagnosed with COVID-19 may return to work. The interim guidance, Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings (July 20, 2020), is focused on when individuals diagnosed with COVID-19 may end home isolation. It is also incorporated

On July 15, 2020, the Virginia Safety and Health Codes Board passed first-in-the-nation codified emergency temporary standards (the Standards) establishing requirements for employers to control, prevent, and mitigate the spread of SARS-CoV-2 (COVID-19) in the workplace. The Standards were issued at the direction of the Governor to create enforceable regulations. With these Standards, the Virginia

The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will begin in March 2021. The IA rule requires food facilities covered by the rule to develop and implement a food defense plan that identifies

The U.S. Food and Drug Administration (FDA) recently released its “Blueprint for the Future” (Blueprint) as part of the New Era of Smarter Food Safety initiative. Launched in April 2019, this effort seeks to build upon FDA’s work implementing the FDA Food Safety Modernization Act (FSMA) by establishing a new approach to food safety that

A recent action by the National Advertising Division (NAD), a self-regulatory arm of the Better Business Bureau, addresses the level of proof necessary to support “natural” and “satiety” claims involving competing experts and a variety of scientific data in dispute. The Proctor & Gamble Company (P&G) successfully challenged three claims made by GlaxoSmithKline Consumer Healthcare,

Dr. Stephen M. Hahn, the Commissioner of Food and Drugs for the Food and Drug Administration (FDA) issued a statement on July 10, 2020, describing the agency’s intentions and approach to resuming domestic inspections in light of the COVID-19 pandemic. After temporarily suspending inspections in March 2020, FDA is working toward restarting on-site inspections during

The Centers for Disease Control and Prevention (CDC) has issued a guidance document titled Testing Strategy for COVID-19 in High-Density Critical Infrastructure Workplaces after a COVID-19 Case is Identified (the Guidance), which describes different testing strategy options for exposed employees when companies determine testing is needed to help support existing disease control measures. As part

The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) recently released several guidelines for various segments of the food industry to address the COVID-19 pandemic. First, CDC issued Interim Guidance from CDC and the U.S. Department of Labor, Agriculture Workers and Employers (“the Interim Guidance”), which provides recommendations related to COVID-19

The U.S. Food and Drug Administration (FDA) recently provided an update from FDA Commissioner Stephen Hahn M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas on the forthcoming New Era of Smarter Food Safety Blueprint (Blueprint), which will outline the agency’s strategy to create “a more digital, traceable, and safer food system” over

On May 27, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance for human food establishments on voluntarily reporting to FDA temporary closures or significantly reduced production due to the COVID-19 public health emergency. The agency’s guidance document is entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment